kidney stone disease, urinary stone disease, urolithiasis
Conditions
Interventions
The investigational treatment is ECIRS. This is a combined treatment of PCNL and URS. Isolated retrograde URS is already commonly used in daily urological practice for less complex kidney stones which
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adult patient with urolithiasis who has an indication for a percutaneous kidney stone treatment, as determined by the local urologist in accordance with the EAU guidelines on urolithiasis.Written informed consent (or e-consent if possible and supported by the local center) has been obtained.Fully able to understand the Dutch language.
Exclusion criteria
Exclusion criteria: Patient in whom retrograde ureterorenoscopy is not feasible or is contraindicated.Incapacitated patients.Kidney transplant recipients.Patients who are unable to comply with follow-up visits, including CT scans at 4 weeks and 1 year after surgery.Pregnant patients.Inadequate pre-operative CT scan for assessing pre-operative kidney stone location, burden, and volume.Patients with extensive renal papillary calcifications, which may complicate reliable postoperative assessment of the primary outcome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint in this study is the stone-free status as assessed four weeks post-operatively by low-dose non-contrast abdominal CT (NCCT). Patients will be analysed for a fully stone free status, which will be formulated as having no residual fragments on NCCT (0mm stone free grade A status). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are as follows:Differences in 4mm (grade C) and 2mm (grade B) stone fragments on the 4-week CT-scan.The presence of stone related events after 4 weeks (outpatient visit), 1 year (outpatient visit), 3 years (telephone interview) and 5 years (telephone interview), described as follows: emergency department visits or hospital admissions because of (suspected) urolithiasis in the ipsilateral kidney; deviations from follow-up (emergency consults) because of pain complaints of suspected ipsilateral urolithiasis; re-interventions of the ipsilateral side because of residual fragments, such as an additional operative procedure (ECIRS, PCNL, URS or ESWL); ureteral stent placement (double J catheter) ipsilaterally; percutaneous nephrostomy tube insertion ipsilaterally.Stone free rates as determined by the 1 year postoperative CT scan.Stone volume rates at the postoperative 4-week and 1-year CT scan.Quality of life assessments at the outpatient visits 1-year and 3-year postoperatively (and if differences persist, 5-years postoperatively), compared to a preoperative status.Postoperative complications to be registered at 4 weeks and at 1 year after the surgery.Radiation exposure as determined by the total amount of radiation of the pre-operative CT-scan, the surgery itself, the 4-week scan, the 1-year scan and all the additional interventions and scans performed for (suspected) urolithiasis on the ipsilateral side.Cost-to-benefit analyses performed at 1, 3 and possibly 5 years after surgery.Carbon footprint analyses, if possible and feasible, performed at 1, 3 and 5 years to better enlighten aspects of sustainability. Operative time difference between procedures in minutes will also be calculated, as determined objectively by the time between the first fluoroscopic image and the last fluoroscopic image. | — |
Countries
Netherlands
Contacts
Public ContactC.A. Suijker
Universitair Medisch Centrum Groningen
Outcome results
None listed